Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department

NCT07228052 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2025-16648
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations. This is a randomized, controlled, double-blind, non-inferiority trial conducted at two urban EDs within the Montefiore Health System.

Conditions

Asthma

Keywords

dexamethasone; prednisone; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test Score

  Asthma control will be assessed via administration of the Asthma Control Test (ACT) questionnaire at 4 weeks post-discharge. The ACT questionnaire is comprised of 5 questions which ask participants to recall how asthma symptoms have affected them over the prior 4 weeks. Responses to the 5 questions are rated on a 5-point Likert scale ranging from 1-5, yielding an overall possible scoring range of 5-25. Higher ACT scores are indicative of better asthma control. For this study, an ACT score \>19 indicates well-controlled asthma. Scores will be summarized by study arm using basic descriptive statistics.

  Within 4 Weeks post-discharge, up to 28-30 days

Secondary Outcomes (3)

• ED or Hospitalization for Asthma

  Within 4 Weeks post-discharge, up to 28-30 days

• Change in Quality of Life

  At 2 weeks (at approximately 14-15 days) and 4 weeks post-discharge relative to baseline, up to 28-30 days

• Adverse Effects

  At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 days

Study Arms (2)

Single Intramuscular Steroid Injection

ACTIVE COMPARATOR

Dexamethasone 16mg Intramuscular Single Dose

Drug: Dexamethasone 16mg IM

Oral Steroid Short Course

ACTIVE COMPARATOR

Prednisone 60mg PO for 5 Days

Drug: Prednisone 60mg PO

Interventions

Dexamethasone 16mg IM DRUG

Dexamethasone 16mg Intramuscular Administration Once

Single Intramuscular Steroid Injection

Prednisone 60mg PO DRUG

Prednisone 60mg PO for 5 Days

Oral Steroid Short Course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years old presenting to the ED with an asthma exacerbation
• Diagnosed with asthma per International Classification of Diseases, 10th Revision (ICD-10) criteria or by the treating clinician
• Discharged from the ED with a primary diagnosis of asthma exacerbation
• Initiated systemic corticosteroids during the ED visit
• Must be English or Spanish speaking

You may not qualify if:

• Current use of systemic corticosteroids, including Emergency Medical Services (EMS) administration before ED arrival
• History of severe adverse reactions to corticosteroids
• Heart failure and uncontrolled diabetes (glucose \>300mg/dL in the ED)
• Pregnancy or breastfeeding as prednisone is the preferred treatment for asthma in this population
• Inability to provide informed consent

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (10)

• Hasegawa K, Craig SS, Teach SJ, Camargo CA Jr. Management of Asthma Exacerbations in the Emergency Department. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2599-2610. doi: 10.1016/j.jaip.2020.12.037. Epub 2020 Dec 31.

  PMID: 33387672 BACKGROUND

• Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.

  PMID: 24515516 BACKGROUND

• Kirkland SW, Cross E, Campbell S, Villa-Roel C, Rowe BH. Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma. Cochrane Database Syst Rev. 2018 Jun 2;6(6):CD012629. doi: 10.1002/14651858.CD012629.pub2.

  PMID: 29859017 BACKGROUND

• Fischer MA, Jones JB, Wright E, Van Loan RP, Xie J, Gallagher L, Wurst AM, Shrank WH. A randomized telephone intervention trial to reduce primary medication nonadherence. J Manag Care Spec Pharm. 2015 Feb;21(2):124-31. doi: 10.18553/jmcp.2015.21.2.124.

  PMID: 25615001 BACKGROUND

• Gordon S, Tompkins T, Dayan PS. Randomized trial of single-dose intramuscular dexamethasone compared with prednisolone for children with acute asthma. Pediatr Emerg Care. 2007 Aug;23(8):521-7. doi: 10.1097/PEC.0b013e318128f821.

  PMID: 17726409 BACKGROUND

• Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.

  PMID: 11445789 BACKGROUND

• Nelsen LM, Kosinski M, Rizio AA, Jacques L, Schatz M, Stanford RH, Svedsater H. A structured review evaluating content validity of the Asthma Control Test, and its consistency with U.S. guidelines and patient expectations for asthma control. J Asthma. 2022 Mar;59(3):628-637. doi: 10.1080/02770903.2020.1861624. Epub 2020 Dec 30.

  PMID: 33377411 BACKGROUND

• Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.

  PMID: 10489826 BACKGROUND

• Alzahrani YA, Becker EA. Asthma Control Assessment Tools. Respir Care. 2016 Jan;61(1):106-16. doi: 10.4187/respcare.04341. Epub 2015 Nov 10.

  PMID: 26556901 BACKGROUND

• Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.

  PMID: 19767070 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Dexamethasone; Prednisone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienediols

Study Officials

• Carlo Lutz, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustfa Manzur, MD MPH MS

CONTACT

718-920-6626; mmanzur@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, treating physicians, nursing, and the investigators will remain blinded to treatment allocation. Blinded medications will be pre-packaged by the clinical research pharmacy team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned 1:1 to a treatment group using a computer-generated randomization schedule.

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 13, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)